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FDA 510(k)

ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT

K-Number: K112456 · 2011-10-04

ApplicantTeleflexmedical, Inc.
Decision Date2011-10-04
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2011-10-04 under 510(k) number K112456. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT?

ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT is a medical device that received FDA 510(k) clearance on 2011-10-04. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K112456.

When did ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT receive FDA 510(k) clearance?

ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT received FDA 510(k) clearance on 2011-10-04, under 510(k) number K112456.

Who is the listed applicant for ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT?

The FDA 510(k) record lists Teleflexmedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT?

The FDA product code for ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT is GCJ.

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Related Devices (Code: GCJ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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